S-HYDROXOCOBA 5000MCG/ML INJ, 30ML glass vial, Red Mountain Compounding Rx
First Royal Care Co. LLC
Lack of Assurance of Sterility
Prescription and over-the-counter medications
First Royal Care Co. LLC
Lack of Assurance of Sterility
First Royal Care Co. LLC
Lack of Assurance of Sterility
First Royal Care Co. LLC
Lack of Assurance of Sterility
Dr. Reddy's Laboratories
CGMP Deviations: Presence of NDMA impurity detected in product.
Dr. Reddy's Laboratories
CGMP Deviations: Presence of NDMA impurity detected in product.
Presence of Particulate Matter.
First Royal Care Co. LLC
Lack of Assurance of Sterility
First Royal Care Co. LLC
Lack of Assurance of Sterility
Marketed without an Approved NDA/ANDA
First Royal Care Co. LLC
Lack of Assurance of Sterility
First Royal Care Co. LLC
Lack of Assurance of Sterility
Marketed without an Approved NDA/ANDA
First Royal Care Co. LLC
Lack of Assurance of Sterility
First Royal Care Co. LLC
Lack of Assurance of Sterility
First Royal Care Co. LLC
Lack of Assurance of Sterility
Arbor Pharmaceuticals
Labeling:Label Mix-up: Shipper Carton labelled Testosterone Cypionate Injection, USP, 200mg/mL, 1 ml single-dose vials, found to contain shelf cartons labelled as Testosterone Cypionate Injection USP, 200mg/mL, 10 ml multi-dose vials which contain Testosterone Cypionate Injection USP, 200mg/mL,1mL single-does vials
Labeling: Incorrect or missing package insert.
Nephron Pharmaceuticals Corporation
Incorrect labeling: Incorrect or missing lot and/or exp date
Innoveix Pharmaceuticals
Lack of Sterility Assurance.
Taro Pharmaceuticals U.S.A.
Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.